Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:41 PM
Study NCT ID:
NCT07473934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total operative time', 'timeFrame': 'baseline', 'description': 'total length of the procedure/total operative time (in minutes)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Laparoscopy']}, 'descriptionModule': {'briefSummary': "Laparoscopy is a minimally invasive technique employed for diagnostic and surgical approaches. Minimally invasive technique compared to laparotomy offer the advantages such as reduced hospital stay, lower morbidity, reduced pain, and faster recovery(1). It has become the primary approach for diagnosing and treating gynecological diseases, favored for both benign and malignant conditions involving the uterus, ovaries, and fallopian tubes, as well as for diagnostic evaluations in cases like chronic pelvic pain and infertility (2).\n\nAccess to the abdomen is the main challenge of laparoscopic surgery. To minimize entry-related injuries like, subcutaneous emphysema, gastrointestinal tract perforation, and minor and major vascular injury for creation of pneumoperitoneum. Several techniques, instruments, and approaches have been introduced. Despite widespread awareness of laparoscopic entry guidelines, considerable variation in the techniques was adopted in clinical practice(3) However, the initial step of accessing the abdominal cavity presents inherent challenges, especially in patients with previous cesarean sections, whose abdominal anatomy may be altered by adhesions or scar tissue(4).\n\nSeveral methods are used for laparoscopic entry. The most common techniques include Veress needle insertion (VNI), direct optical trocar entry, direct trocar insertion (DTI), and the Hasson technique(5).\n\nVNI is the most common method that is used nowadays despite its slow insufflation rates and fatal complications .Veress needle can be introduced periumbilical or in the left hypochondrium. The Palmer's point is a favoured option for periumbilical Veress needle insertion. The point is located 3 cm below the left costal border at the mid-clavicular line. Many studies have found that there are safer and more effective alternate procedures for peritoneal access in patients following abdominal surgery(6).\n\nThe DTI technique requires the advancing of the trocar with a blind twisting motion into the peritoneum after the elevation of the anterior abdominal wall with one hand or with towel clamps. If visual inspection with the camera confirms proper placement, pneumoperitoneum is established with the insufflation of a gas. VN requires the insertion and retraction of a spring-loaded needle with an external diameter of 2 mm. When the tip of the needle penetrates through tissues and enters the peritoneal cavity, the inner stylet springs forward. Then, carbon dioxide is insufflated creating a pneumoperitoneum(7)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous abdominal and pelvic surgeries\n* patients age \\> 19 years\n\nExclusion Criteria:\n\n* Massive bowel distension\n* BMI \\>35'}, 'identificationModule': {'nctId': 'NCT07473934', 'briefTitle': 'Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Direct Trocar Versus Verres Needle Entry at Gynecologic Laparoscopy in Previous Scarred Abdomen: A Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'Direct Trocar Versus Vs Needle'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Trocar group', 'interventionNames': ['Procedure: Direct Trocar']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verres Needle Entry', 'interventionNames': ['Procedure: Veress Needle Entry']}], 'interventions': [{'name': 'Veress Needle Entry', 'type': 'PROCEDURE', 'description': 'a stab incision will be made on the selected site for entry (usually transumbilical or umbilical superior crease). The lifting of the abdominal wall will be performed with the non-dominant hand in all cases. The reusable Veress needle fortified with "spring-loaded obturator" will be introduced intraperitoneally at an angle of approximately 90ยบ by the surgeon holding the needle like a dart. The double-click safety test will be employed to verify the precise intraperitoneal location for the needle. This will be followed by attachment of the gas tube to the Veress needle for gas insufflation. Once satisfactory pneumoperitoneum will be realized, the Veress needle will be detached with the subsequent extension of the stab incision to 11 mm incision. The sharp pointed reusable Trocar/cannula will be inserted by rotary movement as described above.', 'armGroupLabels': ['Verres Needle Entry']}, {'name': 'Direct Trocar', 'type': 'PROCEDURE', 'description': "patient's abdominal wall before the insertion, a transverse or vertical umbilical incision of 1-1.5cm with the scalpel will be made to easily accommodate the first trocar.\n\nThe trocar will be inserted until it came into contact with the muscular fascia at an angle of 90o. Subsequently, the abdominal wall will be elevated, caudal to the umbilical scar, creating a tent between the parietal peritoneum and the intracavitary structures.\n\nThe anterior abdominal wall will be adequately elevated by hand, and the trocar will be inserted directly into the abdominal cavity, aiming towards the pelvic hollow.\n\nThe trocar will be gently inserted into the abdominal cavity at an angle of 45o towards the pelvis, until the click of the security system will be perceived. This indicates the retraction of the blade secondary to the pressure change produced by its entry. There is hissing sound of air gushing in peritoneal cavity will be heard and as air entered the cavity all content fall from the ab", 'armGroupLabels': ['Direct Trocar group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'Sedek Ahmed Sedek', 'investigatorAffiliation': 'Assiut University'}}}}